South Korean pharmaceutical firms LG Chem Ltd. and JW Pharmaceutical Corp. are recouping and pressing on with their respective novel gout drugs internationally, with each having faced regulatory setbacks from IND rejections overseas.
Delcath Systems Inc. reported that the FDA approved its Hepzato Kit for the treatment of adults with unresectable hepatic-dominant metastatic uveal melanoma (mUM). The FDA nod also triggered a second tranche of financing of approximately $35 million from a private placement in March.
Adalta Ltd. is gearing up to begin phase II trials of its lead i-body candidate, AD-214, in idiopathic pulmonary fibrosis (IPF), but it is hoping to find a pharma partner to fund the trials.
Kelun-Biotech Biopharmaceutical Co. Ltd.’s trophoblast cell-surface antigen 2 (Trop2)-targeted antibody-drug conjugate (ADC), SKB-264, met the primary endpoint of progression-free survival (PFS) in a phase III trial in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC), according to an interim analysis.
Variable muscle expression of frataxin (FXN) protein in muscle plus five adverse events (AEs) of injection-site thrombophlebitis in the multiple ascending-dose (MAD) phase I study hamstrung Design Therapeutics Inc. in its Friedreich’s ataxia (FA) bid with DT-216. Wall Street punished the Carlsbad, Calif.-based firm’s stock (NASDAQ:DSGN) with a knockdown of 70%, or $5.17, leaving shares at $2.17 when the market closed Aug. 15.
Shares in Galecto Inc. (NASDAQ:GLTO) plummeted by 71%, closing Aug. 15 at 67 cents, on news that its lead drug candidate, GB-0139, flamed out in a phase IIb trial in idiopathic pulmonary fibrosis (IPF). The inhaled galectin-3 inhibitor actually performed considerably worse than placebo in the 52-week placebo-controlled study, the endpoint of which was the annual rate of decline from baseline in forced vital capacity (FVC).
Kelun-Biotech Biopharmaceutical Co. Ltd.’s trophoblast cell-surface antigen 2 (Trop2)-targeted antibody-drug conjugate (ADC), SKB-264, met the primary endpoint of progression-free survival (PFS) in a phase III trial in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC), according to an interim analysis. The randomized, controlled, open-label, multicenter phase III trial compared injectable SKB-264 (also known as KL-A264 and MK-2870) vs. investigator-selected regimens in patients who failed second-line or above prior standard-of-care therapies.
Terns Pharmaceuticals Inc.’s unveiled positive top-line data from the phase IIa Duet study testing TERN-501, an oral thyroid hormone receptor-beta (THR-B) agonist, given as a monotherapy or in combination with TERN-101, a liver-distributed farnesoid X receptor agonist, for the treatment of nonalcoholic steatohepatitis (NASH).
With a phase II failure, Palisade Bio Inc. has decided to halt development into one of two indications for its only asset, LB-1148. The oral formulation of a broad-spectrum serine protease inhibitor missed the primary endpoint in the Profile study of reducing intra-abdominal adhesions after bowel resection. Palisade said the safety data and efficacy results no longer support further development of LB-1148 in the indication.
There have been no signs of liver damage with Novartis AG’s oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib for treating chronic spontaneous urticaria, top-line results from two phase III trials show, suggesting that faith in the faltering BTK space could be restored.
RSS
